BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 495284 · Received November 6, 2003

    Report

    Report Number
    2031702-2003-00320
    Event Type
    Malfunction
    Date Received
    November 6, 2003
    Report Date
    November 6, 2003
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PULMONETIC SYSTEMS, INC. RECEIVED THE FOLLOWING REPORT FROM A REP OF :LTV WAS RUNNING ON DC FROM CIG. LIGHTER ON A CAR VIA PULMONETIC CIG. LIGHTER CONNECTOR CABLE, WHEN THE CARE WAS STANDING STILL (MOTOR STILL RUNNING) THE LTV TURNED ITSELF OFF, IT DID NOT GO OVER TO THE FULLY CHARGED INTERNAL BATTERY. IN ORDER TO BE ABLE TO TURN THE LTV ON AGAIN THE CIG. LIGHTER CABLE HAD TO BE REMOVED, THEN THE LTV COULD BE STARTED ON INTERNAL BATTERY AND THEN THE CIG. LIGHTER CABLE COULD BE RECONNECTED AND THE UNIT SWITCHED OVER TO EXTERNAL DC AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK PULMONETIC SYSTEMS, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other